1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 14602:2011Non-active surgical implants Implants for osteosynthesisParticular requirements (ISO 14602:2010)BS EN ISO 14602:2011 BRITISH STANDARDNational forewordThis Bri
2、tish Standard is the UK implementation of EN ISO14602:2011. It is identical to ISO 14602:2010. It supersedes BS EN ISO14602:2010 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/150/5, Surgical Implants - Osteosynthesis and spinaldevices.A list of org
3、anizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. BSI 2011ISBN 978 0 580 76946 7ICS 11.040.40Compliance with a British Standard
4、cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 October 2011.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14602 October 2011 ICS 1
5、1.040.40 Supersedes EN ISO 14602:2010English Version Non-active surgical implants - Implants for osteosynthesis - Particular requirements (ISO 14602:2010) Implants chirurgicaux non actifs - Implants pour ostosynthse - Exigences particulires (ISO 14602:2010)Nichtaktive chirurgische Implantate - Impla
6、ntate zur Osteosynthese - Besondere Anforderungen (ISO 14602:2010) This European Standard was approved by CEN on 20 September 2011. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national stan
7、dard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in a
8、ny other language made by translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Rep
9、ublic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN D
10、E NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 14602:2011: EBS EN ISO 14602:2011EN ISO 14602:2011 (E) 3 Foreword This doc
11、ument (EN ISO 14602:2011) has been prepared by Technical Committee ISO/TC 150 “Implants for surgery“ in collaboration with Technical Committee CEN/TC 285 “Non-active surgical implants” the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, e
12、ither by publication of an identical text or by endorsement, at the latest by April 2012, and conflicting national standards shall be withdrawn at the latest by April 2012. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. CEN and/o
13、r CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 14602:2010. This new edition contains a revised Annex ZA. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Associa
14、tion, and supports essential requirements of EU Directive. For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to impleme
15、nt this European Standard: Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switz
16、erland and the United Kingdom. Endorsement notice The text of ISO 14602:2010 has been approved by CEN as EN ISO 14602:2011 without any modification. BS EN ISO 14602:2011EN ISO 14602:2011 (E) 4 Annex ZA (informative) Relationship between this European Standard and the Essential Requirements of EU Dir
17、ective 93/42/EEC This European Standard has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association to provide a means of conforming to Essential Requirements of the New Approach Directive 93/42/EEC on medical devices as amended by Directive 2007
18、/47/EC. Once this standard is cited in the Official Journal of the European Union under that Directive and has been implemented as a national standard in at least one Member State, compliance with the clauses of this standard given in Table ZA.1 confers, within the limits of the scope of this standa
19、rd, a presumption of conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations. Table ZA.1 Correspondence between Directive 93/42/EEC and this European Standard Clause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs) of Directiv
20、e 93/42/EEC Qualifying remarks/Notes 5, 7, 8 and 10 7.2 6 7.3 5 7.5 1stsentence 5 and 6 7.6 10 8.3 9 8.4 9 8.5 10 8.6 11.2 8.7 11.4 9.1 5 and 6 9.2 2ndindent 11.1 13.2 11.2 13.3 a) 1stsentence 11.2 13.3 b) 11.2 13.3 c) 11.2 13.3 d) 11.2 13.3 e) 11.2 13.3 f) 11.6 13.3 g) 11.6 13.3 h) 10 and 11.2 13.3
21、 i) 11.2 13.3 j) BS EN ISO 14602:2011EN ISO 14602:2011 (E) 5 Clause(s)/sub-clause(s) of this European Standard Essential Requirements (ERs) of Directive 93/42/EEC Qualifying remarks/Notes 11.2 13.3 k) 11.2 13.3 m) 11.2 and 11.3 13.4 4.3 13.5 11.3 13.6 a)11.3 and 11.4 13.6 c) 11.3 13.6 e)9 13.6 g)9 1
22、3.6 i) 11.3 b) 13.6 k) 11.3 13.6 n)11.3 b) 13.6 q) WARNING Other requirements and other EU Directives may be applicable to the product(s) falling within the scope of this standard. BS EN ISO 14602:2011ISO 14602:2010(E) ISO 2010 All rights reserved iiiContents Page Foreword iv Introduction.v 1 Scope1
23、 2 Normative references1 3 Terms and definitions .1 4 Intended performance.1 4.1 General .1 4.2 Intended purpose 2 4.3 Functional characteristics2 4.4 Intended conditions of use.3 5 Design attributes .3 6 Materials .4 7 Design evaluation4 7.1 General .4 7.2 Pre-clinical evaluation.4 7.3 Clinical eva
24、luation .4 7.4 Post-market surveillance4 8 Manufacturing5 9 Sterilization 5 10 Packaging.5 11 Information supplied by manufacturer5 11.1 General .5 11.2 Labelling.5 11.3 Instructions for use .5 11.4 Restrictions on combinations5 11.5 Marking on implant5 11.6 Marking for special purposes 5 Annex A (i
25、nformative) Correspondence of the clauses of this International Standard to the fundamental principles outlined in ISO/TR 142836 Annex B (informative) ISO standards referring to implants and associated instruments found acceptable through clinical use for given applications in osteosynthesis.7 Annex
26、 C (informative) ISO Standards referring to materials found acceptable through proven clinical use .10 Annex D (informative) Standards related to testing and design evaluation .12 Bibliography13 BS EN ISO 14602:2011ISO 14602:2010(E) iv ISO 2010 All rights reservedForeword ISO (the International Orga
27、nization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been establis
28、hed has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization
29、. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. P
30、ublication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such pate
31、nt rights. ISO 14602 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC 5, Osteosynthesis and spinal devices. This second edition cancels and replaces the first edition (ISO 14602:1998), which has been technically revised. BS EN ISO 14602:2011ISO 14602:2010(E) ISO
32、2010 All rights reserved vIntroduction In general, non-active surgical implants for osteosynthesis are used in trauma treatment or corrective surgery. They maintain the reduction of fractured bones and stabilize bony (or adjacent) structures to allow bone healing or fusion and/or to provide support
33、or correction. When they have achieved their objective, the implants are either retrieved or left in situ. This International Standard, in addition to the requirements in ISO 14630, provides a method for addressing the fundamental principles in ISO/TR 14283 as they apply to non-active surgical impla
34、nts for osteosynthesis. Annex A shows the correspondence between the clauses of this International Standard and those of ISO/TR 14283:2004. This International Standard also provides a method of demonstrating compliance with the relevant essential requirements (ERs) as outlined in general terms in An
35、nex 1 of European Council Directive 93/42/EEC of 14 June 1993 concerning medical devices, amended by Directive 2007/47/EC of 5 September 2007, as they apply to non-active surgical implants for osteosynthesis. It might also assist manufacturers to comply with the requirements of other regulatory bodi
36、es. Alternative methods of demonstrating compliance might be acceptable, in particular with respect to implants which have demonstrated satisfactory long-term clinical performance. There are three levels of standard concerned with non-active surgical implants and related instrumentation. For the imp
37、lants themselves, there are the following levels, with level 1 being the highest: level 1: general requirements for non-active surgical implants; level 2: particular requirements for families of non-active surgical implants; level 3: specific requirements for types of non-active surgical implants. L
38、evel 1 standards contain requirements that apply to all non-active surgical implants. They also indicate that additional requirements are given in the level 2 and level 3 standards. Level 2 standards, such as this International Standard, contain requirements that apply to a more restricted set or fa
39、mily of non-active surgical implants. This International Standard is a Level 2 standard that lays down particular requirements for non-active surgical implants for osteosynthesis that are in addition to those general requirements stated in ISO 14630 for non-active surgical implants. It is to be appl
40、ied in conjunction with ISO 14630. Level 3 standards, such as those listed in the annexes, apply to specific types of implant within a family of non-active surgical implants, in this case particular types of non-active surgical implant for osteosynthesis. To address all requirements for a specific i
41、mplant, it is advisable that the standard of the lowest available level be consulted first. NOTE The requirements in this International Standard correspond to international consensus. Individual or national standards or regulatory bodies can prescribe other requirements. BS EN ISO 14602:2011BS EN IS
42、O 14602:2011INTERNATIONAL STANDARD ISO 14602:2010(E) ISO 2010 All rights reserved 1Non-active surgical implants Implants for osteosynthesis Particular requirements 1 Scope This International Standard specifies particular requirements for non-active surgical implants for osteosynthesis, hereafter ref
43、erred to as implants. In addition to ISO 14630, this International Standard gives particular requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. 2 Normative references The follow
44、ing referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 14630:2008, Non-active surgical implants General requir
45、ements 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 14630 and the following apply. 3.1 non-active surgical implant for osteosynthesis non-active implantable device intended to provide support to bony, cartilaginous, tendinous or ligamentous struct
46、ures 4 Intended performance 4.1 General The intended performance of implants shall conform to ISO 14630:2008, Clause 4, taking account of the additional aspects listed in 4.2, 4.3 and 4.4 as applicable. NOTE Because of variations in anatomy, fracture sites and applications, it is necessary that impl
47、ants for osteosynthesis be versatile. For anatomical reasons the size of the implants is necessarily restricted. The condition of the bone and the configuration of bony and other defects can affect the performance of the implants. BS EN ISO 14602:2011ISO 14602:2010(E) 2 ISO 2010 All rights reserved4
48、.2 Intended purpose The intended purpose is osteosynthesis, which can include the areas of application listed below. In describing and documenting the implants intended performance for osteosynthesis, the area(s) of intended typical application(s) shall be specified, for example: a) fracture treatme
49、nt; b) tumour treatment; c) stabilization of osteotomy; d) stabilization of arthrodesis; e) bone lengthening, shortening or transport; f) support of bone replacement (bone graft sites); g) adjunct to joint replacement; h) scoliosis treatment; i) spinal stabilization; j) treatment of degenerative diseases; k) tendon reconstruction; l) ligament reconstruction. NOTE Where appropriate, the anatomical site(s) should be indicated. 4.3 Functional characteristics In describing and documenting the functional characteristics of the implants, the follow
